a. Field of Invention
The invention relates generally to the treatment of involuntary urinary incontinence, and, more particularly to a surgically implantable device operable by a user to prevent or allow bladder emptying by the application of predetermined forces on the device.
b. Description of Related Art
In the art, there presently exist a variety of known surgical treatments for incontinence. Typical surgical treatments include the removal of prostatic obstruction, periurethral injections of obstructive collagen, nerve de-enervation, insertion of artificial urinary sphincters, supporting the urethral-vesical angle with pubovaginal slings and various other methods of surgical urethral bladder neck suspension. In males, while external condom catheters, penile/urethral clamps or indwelling bladder catheters have been used as the simplest therapeutic solutions, these solutions have been both psychologically and operationally deficient for a patient.
Of the aforementioned surgical incontinence treatments, pelvic sling procedures generally use a mesh material for compressing the urethra. Artificial urinary sphincters typically surround the urethra completely, and include an attached separate fluid reservoir implanted in the pelvis. The surgical procedure of urethral bladder neck suspension corrects the position of the bladder and urethra by sewing the bladder neck and urethra directly to the surrounding pelvic bone or nearby structures. These procedures are problematic due to the requirement of extensive surgical dissection for insertion, the propensity for mechanical failure and leaks, and difficulty in the operation of the devices associated with the procedures. Further, these procedures often require post-operative surgical intervention and/or repair in nearly one-half of the patients.
Known prior incontinence treatments are disclosed for example in U.S. Pat. No. 5,888,188 to Srougi et al., U.S. Pat. No. 6,691,711 to Raz et al., and U.S. Pat. No. 6,609,522 to Cheng et al., the respective disclosures of which are incorporated herein by reference.
U.S. Pat. No. 5,888,188 to Srougi et al., as shown in FIG. 1 thereof, discloses a mechanical sphincter device 1 including a semi-annular piece 2. Attached to the semi-annular piece 2 are two strips 3 configured to surround a urethra when sphincter 1 is surgically implanted in a user's urethra. In use, sphincter 1 prohibits passage of urine through the urethra unless the user compresses the sphincter. More specifically, as shown in FIG. 4, a user applies pressure upon the free ends of semi-annular piece 2, causing loosening of the two strips 3 to release the flow of urine through the urethra.
An exemplary drawback of the mechanical sphincter of Srougi et al. is that the urethra is completely surrounded when the sphincter is in the resting position. More importantly, any device that completely surrounds the urethra poses a threat of ischemic injury and is prone to mechanical failure and leaks. Additionally, use of mechanical sphincter 1 requires consistent opposing forces by at least two digits of the user during the release of urine. The present invention thus purports to overcome at least the aforementioned exemplary drawbacks of the treatment disclosed by Srougi et al.
Another type of surgical treatment is disclosed by U.S. Pat. No. 6,691,711 to Raz et al. As shown in FIG. 12 of Raz et al., the surgical treatment includes the insertion and anchoring of a “hammock-like” sling material to bone anchors. The sling material is configured to compress against the bulbar urethra.
While the surgical treatment of Raz et al. overcomes some of the noted drawbacks of the surgical treatment disclosed by Srougi et al., there is no user control. Thus, the surgical treatment of Raz et al. causes permanent compression of the urethra without user control.
Lastly, in U.S. Pat. No. 6,609,522 to Cheng et al, as illustrated in FIG. 1, the incontinence treatment disclosed is an external urethral compression device 10. The device includes an arced structure 12 which acts to compress a urethra when worn by a user as shown in FIG. 3. While the user may have one handed control of the incontinence treatment, external urethral compression devices are prone to urine leakage and may prevent blood circulation to the penis, and most importantly, can be painful when used for extended periods of time.
It would therefore be of benefit to provide a treatment for incontinence including urethral compression and having user controls designed for a first user touch to disengage urethral compression and a second user touch to re-engage urethral compression. It would also be of benefit to provide a surgical treatment that refrains from completely surrounding the urethra. There also remains a need for a surgical treatment which is less prone to mechanical failure, simpler and more economical to manufacture, less invasive to insert, and has superior comfort than the prior art treatment techniques.